[Federal Register: June 22, 2005 (Volume 70, Number 119)]
[Notices]
[Page 36189-36190]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn05-124]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0219]
Guidance for Industry: General Principles for Evaluating the
Safety of Compounds Used in Food-Producing Animals; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance for industry entitled ``General
Principles for Evaluating the Safety of Compounds Used in Food-
Producing Animals (GFI 3).'' This version of the guidance
replaces the version that was made available in July 1994. This has
been revised to remove outdated information on toxicological testing
and to provide references to other available guidance on the topic. In
addition, the document has been revised to address minor formatting
issues.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Mark M. Robinson, Center for
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-5282, e-mail:
mrobinson@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA published the guidance for industry entitled ``General
Principles for Evaluating the Safety of Compounds Used in Food-
Producing Animals (GFI 3)'' in July 1994. Since that time, FDA
has published a number of guidance documents in its participation with
International Cooperation on Harmonization of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH) that provide
recommendations on toxicological testing of compounds used in food-
producing animals. This version of guidance 3 replaces the
version that was made available in July 1994. The guidance has been
updated to remove outdated information on toxicological testing and
refers the reader to the relevant Center for Veterinary Medicine/VICH
guidance documents. In addition, the document was revised to address
minor formatting issues including correcting an error in the numbering
of the guidance sections.
II. Significance of Guidance
This document is being revised as a level 2 guidance consistent
with FDA's good guidance practices regulation (21 CFR 10.115.) The
guidance represents the agency's current thinking on the subject
matter. The document does not create or confer any rights for or on any
person and will not operate to bind FDA or the public. Alternative
methods may be used as long as they satisfy the requirements of the
applicable statutes and regulations.
III. Comments
As with all of FDA's guidances, the public is encouraged to submit
written or electronic comments pertinent to this guidance. FDA will
periodically review the comments in the docket and, where appropriate,
will amend the guidance. The agency will notify the public of any such
amendments through a notice in the Federal Register.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
[[Page 36190]]
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Copies of the guidance document entitled ``General Principles for
Evaluating the Safety of Compounds Used in Food-Producing Animals
(3)'' may be obtained on the Internet from the CVM home page
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.
Dated: June 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12323 Filed 6-21-05; 8:45 am]
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